GLP-1 Policy Tracker: Every Federal Action

Federal policy has done more to change what Americans pay for GLP-1 drugs in the last two years than the drugmakers did in the previous five. This tracker lists the actions in date order, explains what each one actually does, and flags what is still unsettled.

This is a policy explainer. It is not medical advice, and none of it tells you whether a particular drug is right for you. That is a conversation with a healthcare provider.

This page contains no dosing guidance. It does not describe what dose to take, how to change a dose, when to start or stop a medication, or how to combine one with another. Those are set by the FDA-approved prescribing information and Instructions for Use for each product, by your own prescription, and by your provider.

The background rule: the 2003 Medicare exclusion

Everything downstream traces to one provision. The Medicare Modernization Act of 2003 created a statutory exclusion in Medicare Part D for drugs used for weight loss [1]. Part D plans could not cover them, no matter how the clinical evidence developed.

That is why Medicare beneficiaries could get Ozempic for type 2 diabetes but not Wegovy for obesity, and why every attempt to change it since has had to go through either Congress or demonstration authority.

2024: the Congressional Budget Office sets the price of change

The Congressional Budget Office estimated in 2024 that the Treat and Reduce Obesity Act, which would lift the Part D weight-loss exclusion, would increase federal spending by about USD 35 billion over nine years [1].

That number is the reason the bill has repeatedly stalled despite bipartisan support. Every subsequent federal action has been, in one way or another, an attempt to expand access without triggering that score.

May 12, 2025: the most-favored-nation executive order

President Trump signed an executive order titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” [2].

What it does:

• Directs the Secretary of HHS to communicate most-favored-nation price targets to manufacturers, tying US prices to the lowest price offered in other developed nations
• Directs HHS to propose a rulemaking plan if manufacturers do not make significant progress
• Directs HHS to facilitate direct-to-consumer purchasing programs for manufacturers selling at MFN prices

That last clause is the one that created the cash-pay channel that now dominates US GLP-1 volume.

July 31, 2025: letters to manufacturers

The President sent letters to leading pharmaceutical manufacturers setting out the steps required to bring US prices in line with the lowest price offered in other developed nations [2].

September 30, 2025: the Pfizer deal and TrumpRx announcement

The first company agreement was announced with Pfizer [2]. Its components became the template for everything that followed:

• Most-favored-nation pricing for every state Medicaid program on Pfizer products
• MFN prices guaranteed on all new medicines Pfizer brings to market
• Selling many primary care and specialty drugs at an average of half off list through a new website
• A USD 70 billion US manufacturing investment commitment in exchange for a three-year exemption from certain import tariffs [3]

The same day, the administration announced TrumpRx, a direct-to-consumer website where people could buy discounted medications outside insurance, targeted for launch in “early 2026” [2]. The initial Pfizer medicines listed were Eucrisa, Duavee, Zavzpret and Xeljanz [2].

Critics noted immediately that a cash-price site does little for the roughly 92% of Americans with insurance [4].

November 2025: the GLP-1 deals

The administration announced agreements with Eli Lilly and Novo Nordisk covering semaglutide and tirzepatide [5].

Core terms:

• Medicare and state Medicaid programs can buy currently available injectable GLP-1s at about USD 245 per month [6]
• Broader access and better affordability through Medicare Part D, Medicaid and direct-to-patient self-pay [7]
• Products listed on TrumpRx at manufacturer cash prices

Novo Nordisk described the agreement in its own half-year report as covering “broader access and better affordability through Medicare Part D, Medicaid and direct-to-patient self-pay” [7].

November 25, 2025: Medicare negotiates semaglutide

Separately, under the Inflation Reduction Act’s drug price negotiation program, CMS announced final negotiated prices for the second cycle of 15 Part D drugs [8].

Semaglutide, covering Ozempic, Rybelsus and Wegovy, landed at a maximum fair price of USD 274 for a 30-day supply, effective January 1, 2027, a 71% cut from the USD 959 list price used for comparison [8][9].

Scale: semaglutide covered about 2.28 million Medicare Part D enrollees with roughly USD 15.16 billion in gross Part D spending in the lookback period [10]. Across all 15 drugs in the cycle, CMS projected about 44% aggregate net savings, roughly USD 12 billion versus 2024 spending, with Part D enrollees saving about USD 685 million in out-of-pocket costs in 2027 [9][10].

One unresolved oddity: the IRA negotiated price of USD 274 is higher than the USD 245 most-favored-nation price the administration announced for the same products weeks earlier. Health policy researchers flagged it publicly, and Novo said it looked forward to additional clarity from CMS [9].

December 23, 2025: the BALANCE model

CMS unveiled BALANCE — Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth — a voluntary five-year payment model to expand obesity drug access in Medicaid and Medicare Part D through negotiated prices, standardized coverage criteria and lifestyle support [5][11].

Key design facts [11][32]:

• Voluntary for manufacturers, state Medicaid agencies and Part D plans
• Manufacturer notices of intent were due January 8, 2026; Part D plan notices April 20, 2026; state Medicaid applications July 31, 2026
• Both Eli Lilly and Novo Nordisk agreed to participate as manufacturers
• Medicaid coverage could launch as early as May 2026
• States may begin participating on a date of their choosing from May 1, 2026 through January 1, 2027; after that, admission is at CMS’s discretion
• Medicaid arm runs five years, through December 2031
• Medicare Part D participation originally targeted for January 2027

What happened to the Medicare half. In May 2026, CMS said BALANCE would not launch in Medicare Part D in 2027 and delayed that arm indefinitely, extending the separate Medicare GLP-1 Bridge through December 31, 2027 instead [32][33].

What happened to the Medicaid half. It remains live. The state application window closed July 31, 2026, and CMS has not publicly named any participating state; the CMS model page listed the number of participants as not applicable [12][32].

April 2, 2026: the Section 232 pharmaceutical tariff proclamation

This is the largest single federal intervention in pharmaceutical trade in decades.

The President signed a proclamation, “Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients into the United States,” imposing a 100% ad valorem tariff on imported patented pharmaceuticals, their active pharmaceutical ingredients and key starting materials, on national security grounds [13].

Effective dates [13][14]:

• July 31, 2026 for the 17 large companies listed in Annex III
• September 29, 2026 for all other importers

Rate structure [13][15][16]:

Situation	Rate
Default for patented pharmaceuticals and ingredients	100%
EU, Japan, South Korea, Switzerland and Liechtenstein	15%
United Kingdom	10% as written, with a path to zero under a pharmaceutical pricing agreement; the US Trade Representative announced on April 2, 2026 that the UK agreement had been finalized, which trade counsel read as putting UK-origin products at zero when the tariffs take effect [34]
Companies with onshoring plans approved by the Secretary of Commerce	20%, escalating to 100% in 2030
Companies with both MFN pricing agreements and approved onshoring plans	0% through January 20, 2029
Orphan drugs, nuclear medicines, plasma therapies, fertility treatments, cell and gene therapies, urgent US health needs	0%
Generics, biosimilars and US-origin products	excluded at the time of the proclamation

Why GLP-1 prices did not jump. Annex II of the proclamation lists company-specific agreements already entered into with the Secretary of Commerce, including Eli Lilly and Company, dated February 23, 2026, alongside Amgen and Bristol Myers Squibb (December 19, 2025), Boehringer Ingelheim (December 19, 2025), AbbVie and AstraZeneca (both March 20, 2026) [14]. Novo Nordisk reached a US tariff and manufacturing agreement in November 2025 [7]. In practice, the companies that make your GLP-1 negotiated their way to relief before the tariff took effect.

The proclamation also directs the Secretary of Commerce and HHS to keep negotiating onshoring agreements, with a joint status report due to the President by July 1, 2026 [17].

July 21, 2026: the generic drug tariff schedule

The April proclamation exempted generics but directed Commerce to report within a year on whether that should change [13]. The answer came in July.

The President announced that imported generic drugs would face [18][19]:

• 0% for two years from August 1, 2026
• 100% from August 1, 2028, for one year
• 200% from August 2029 onward

The stated purpose was to reshore generic manufacturing, described as “a penalty to those Companies that decide not to build Plant and Equipment within the stated period of time” [18].

For GLP-1 readers this matters mainly for the 2030s: it is the policy that will determine what generic semaglutide costs when its US patents expire around December 2031.

July 1, 2026: the Medicare GLP-1 Bridge launches

CMS announced the Medicare GLP-1 Bridge in December 2025, alongside BALANCE, as a short-term nationwide demonstration under Section 402 authority to carry Medicare beneficiaries until the BALANCE Part D arm started. When CMS delayed that arm indefinitely in May 2026, it extended the Bridge by a year [20][21][32].

How it works [20][21][22][32]:

• Runs July 1, 2026 through December 31, 2027 (originally scheduled to end December 31, 2026, then extended in May 2026)
• Administered outside Part D through a contract with Humana, which serves as the single central processor for prior authorization, claims adjudication and pharmacy payment
• Eligible Part D beneficiaries pay a flat USD 50 copay for a one-month supply
• Covered products as of August 2026: Foundayo tablet, Wegovy injection or tablet, and Zepbound KwikPen only
• Participating manufacturers supply at a net price of about USD 245 per month
• Operates outside the Part D benefit’s normal coverage and payment flow, through a single central processor for prior authorization, claims and pharmacy payment
• Part D sponsors carry no risk and do not have to opt in
• The USD 50 copay does not count toward the Part D deductible or annual out-of-pocket limit, and cannot be reduced by Extra Help
• Beneficiaries in Special Needs Plans, employer or union group waiver plans and the Limited Income Newly Eligible Transition program are excluded
• Beneficiaries with type 2 diabetes or obstructive sleep apnea are ineligible, because Part D should already cover GLP-1s for those conditions

Uptake was fast. CMS Administrator Mehmet Oz said about 250,000 beneficiaries had signed up by July 29, 2026 [23]. The White House reported more than 500,000 by August 31 with USD 216 million in beneficiary savings, and Oz cited about 600,000 the same day [24][25].

KFF estimates about 3.8 million beneficiaries qualify [24]. KFF’s Juliette Cubanski estimated that if a quarter enroll and stay on treatment for the full 18 months, the cost to Medicare would be about USD 3.3 billion; if three-quarters enroll, costs could reach about USD 10 billion [26].

The cliff. The Bridge expires December 31, 2027. Unless the administration extends or replaces it, or Congress changes the law, coverage ends for everyone using it. That creates real uncertainty for people starting what many clinicians describe as long-term therapy [1].

August-September 2026: the deal wave broadens

By September 1, 2026, more than 20 pharmaceutical companies had publicly announced drug-pricing agreements with the administration [27].

• The first wave of 17 major drugmakers included commitments to MFN pricing, TrumpRx sales and US investment pledges in exchange for tariff relief
• A second wave, announced in late August 2026, added nine companies, including smaller biotechs, mostly offering drugs to state Medicaid programs at MFN prices [27]
• Reported aggregate commitments from that second wave included about USD 19.6 billion in additional US manufacturing [28]
• India’s Sun Pharma received a two-year delay on potential US tariffs on its innovative drugs in exchange for discounted Medicaid medicines; Belgium’s UCB agreed to more balanced pricing, a Medicaid program, expanded US manufacturing and stockpile donations [27]

Bloomberg Government reported that through these agreements the administration had negotiated prices on most popular GLP-1s, though costs across brands and forms still ranged from USD 149 to USD 299 a month on TrumpRx, with some reduced prices lasting only a limited time [1].

What Congress is doing

No major GLP-1-specific statute had passed as of September 2026. Active items:

Treat and Reduce Obesity Act. Reintroduced in February 2026 [29]. It would lift the Part D weight-loss exclusion and make obesity drug coverage permanent rather than dependent on demonstration authority. The CBO’s USD 35 billion nine-year estimate remains the obstacle [1].

S. 3794, the Safeguarding Americans from Fraudulent and Experimental Drugs Act. Bipartisan legislation that would give FDA more authority over compounding facilities: requiring compounding manufacturers to report activity to FDA, mandating inspections, and capping how many copies of a drug may be produced each month [1].

Pharmacy benefit manager reform. A January 30, 2026 federal rule addressed transparency into PBM fee disclosure [30]. Bipartisan proposals would require PBMs to reimburse pharmacies at National Average Drug Acquisition Cost plus a state dispensing fee in Medicaid managed care [31].

The three dates that matter next

September 29, 2026. The Section 232 tariff regime takes effect for every importer not listed in Annex III, who have been covered since July 31, 2026.

January 1, 2027. Three things happen at once: the Medicare negotiated price of USD 274 takes effect, Novo’s US list prices drop to USD 675 a month, and the last date passes on which a state Medicaid agency can begin participating in BALANCE as of right. Note that the application deadline for states was July 31, 2026, and has already passed; after January 1, 2027 a state can join only at CMS’s discretion.

December 31, 2027. The Medicare GLP-1 Bridge ends. Without legislation or a further extension, several hundred thousand or more Medicare beneficiaries lose the USD 50 copay.

Around April 2, 2027. Commerce’s reassessment of whether generics and biosimilars should stay outside the Section 232 tariff is due, one year after the proclamation.

August 1, 2028. The 100% generic drug tariff begins, three years before semaglutide’s US compound patent expires on December 5, 2031.

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Sources

1. Bloomberg Government, “Congress Takes Fresh Look at GLP-1 Legislation on Cost, Safety.” https://news.bgov.com/bloomberg-government-news/congress-takes-fresh-look-at-glp-1-legislation-on-cost-safety
2. Healthcare Perspectives (Dinsmore), “Trump Administration Announces Deal with Pfizer on Most-Favored-Nation Drug Pricing and Launch of TrumpRx,” October 20, 2025. https://www.healthcareperspectivesblog.com/2025/10/trump-administration-announces-deal-with-pfizer-on-most-favored-nation-drug-pricing-and-launch-of-trumprx
3. HNGN, “Pfizer to Slash Drug Prices as Trump Announces Launch of ‘TrumpRx’ Website,” October 1, 2025. https://www.hngn.com/articles/268304/20251001/pfizer-slash-drug-prices-trump-announces-launch-trumprx-website.htm
4. Axios, “TrumpRx website: What to know about launch date, costs,” October 1, 2025. https://www.axios.com/2025/10/01/trumprx-website-drug-prices-trump-pfizer
5. Reuters, “US health agency unveils weight-loss drug coverage model,” December 23, 2025. https://www.reuters.com/business/healthcare-pharmaceuticals/us-health-agency-expand-access-glp-1-weight-loss-drugs-2025-12-23
6. ACHI, “Trump Administration Announces New Voluntary Payment Model for Weight-Loss Drugs,” January 6, 2026. https://achi.net/newsroom/trump-administration-announces-new-voluntary-payment-model-for-weight-loss-drugs
7. Novo Nordisk, “Financial report for the period 1 January 2026 to 30 June 2026,” August 4, 2026. https://attachment.news.eu.nasdaq.com/a0078e15b379bff5e3b0ffdbddb3d5075
8. CMS, “Medicare Drug Price Negotiation Program: Negotiated Prices for Initial Price Applicability Year 2027.” https://www.cms.gov/files/document/fact-sheet-negotiated-prices-ipay-2027.pdf
9. NPR, “Medicare negotiated lower prices for 15 drugs, including 71% off Ozempic and Wegovy,” November 26, 2025. https://www.npr.org/sections/shots-health-news/2025/11/26/nx-s1-5621944/medicare-drug-prices-ozempic-and-wegovy
10. IntuitionLabs, “Medicare Drug Price Negotiation List: All Drugs and Prices.” https://intuitionlabs.ai/articles/medicare-drug-price-negotiation-list
11. CMS, “BALANCE (Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth) Model.” https://www.cms.gov/priorities/innovation/innovation-models/balance
12. Medical Daily, “The Federal Deal to Cut Medicaid Prices on Weight Loss Drugs Still Names No Participating States.” https://www.medicaldaily.com/balance-model-medicaid-glp1-state-participation-coverage-gap-477723
13. The White House, “Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients into the United States,” April 2, 2026. https://www.whitehouse.gov/presidential-actions/2026/04/adjusting-imports-of-pharmaceuticals-and-pharmaceutical-ingredients-into-the-united-states
14. Federal Register public inspection document 2026-06956, Annexes to the pharmaceutical tariff proclamation, filed April 8, 2026. https://public-inspection.federalregister.gov/2026-06956.pdf
15. Ropes & Gray, “100% On Brand: U.S. Imposes New Tariffs (and Key Exemptions) on Patented Pharmaceuticals,” April 2026. https://www.ropesgray.com/en/insights/alerts/2026/04/100-on-brand-us-imposes-new-tariffs-and-key-exemptions-on-patented-pharmaceuticals
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18. Reuters, “Trump says generic drugs to face no US tariffs for 2 years, then 100% and 200% tariffs later,” July 21, 2026. https://www.reuters.com/business/healthcare-pharmaceuticals/trump-says-generic-drugs-face-no-us-tariffs-2-years-before-rates-100-200-later-2026-07-21
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20. CMS, “Medicare GLP-1 Bridge: Information for Pharmacies.” https://www.cms.gov/medicare/coverage/prescription-drug-coverage/medicare-glp-1-bridge/information-pharmacies
21. National Council on Aging, “What Is the Medicare GLP-1 Bridge Program?” https://www.ncoa.org/article/expanding-access-to-weight-loss-medications-the-medicare-glp-1-bridge-program
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23. NPR, “Medicare’s $50 obesity drug program is proving popular,” August 26, 2026. https://www.npr.org/2026/08/26/nx-s1-5940761/medicare-weight-loss-drugs
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25. Newsweek, “Medicare Update: Hundreds of Thousands Get GLP-1 Drugs for Just $50,” August 31, 2026. https://www.newsweek.com/medicare-update-hundreds-of-thousands-get-glp-1-drugs-for-just-50-12388495
26. KFF Health News, “The Medicare GLP-1 Discount Has One Big Catch,” August 25, 2026. https://kffhealthnews.org/aging/medicare-glp1-bridge-weight-loss-drugs-coverage-exceptions-cost-access
27. Reuters, “Global pharma companies that have publicly announced Trump drug pricing agreements,” September 1, 2026. https://www.reuters.com/business/healthcare-pharmaceuticals/global-pharma-companies-that-have-publicly-announced-trump-drug-pricing-2026-09-01
28. Pharmaceutical Commerce, “How GLP-1 Growth and Specialty Drugs Are Driving Cost Pressure.” https://www.pharmaceuticalcommerce.com/view/how-glp1-growth-and-specialty-drugs-are-driving-cost-pressure
29. CNBC, “Medicare obesity drug GLP-1 coverage starting July 1,” June 30, 2026. https://www.cnbc.com/2026/06/30/medicare-obesity-drug-glp-1-coverage-starting-july-1.html
30. Federal Register, “Improving Transparency Into Pharmacy Benefit Manager Fee Disclosure,” January 30, 2026. https://www.federalregister.gov/documents/2026/01/30/2026-01907/improving-transparency-into-pharmacy-benefit-manager-fee-disclosure
31. Forbes, “Why 2025 Could Be A Good Reimbursement Year For CVS And Walgreens,” December 22, 2024. https://www.forbes.com/sites/brucejapsen/2024/12/22/why-2025-could-be-a-good-reimbursement-year-for-cvs-and-walgreens
32. KFF, “What to Know About the BALANCE Model for GLP-1s in Medicare and Medicaid.” https://www.kff.org/medicare/what-to-know-about-the-balance-model-for-glp-1s-in-medicare-and-medicaid
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34. Mondaq / Arnold & Porter, “Trade Winds Shift for Pharma: Understanding the Section 232 Tariff Proclamation on Pharmaceuticals,” April 2026. https://www.mondaq.com/unitedstates/international-trade-investment/1771056/trade-winds-shift-for-pharma-understanding-the-section-232-tariff-proclamation-on-pharmaceuticals